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A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020

Inclusion Criteria


Inclusion

- Patient has provided informed consent documented by signing the Informed Consent Form
(ICF) prior to any study-related procedures

- Patient achieved complete clearance of AK lesions (lesion count of 0) in the selected
treatment area at the Day 57 visit in study PEP005-020

Exclusion

- Concurrent participation in another research study which would involve the selected
treatment area (except for any post-study follow-up visits for previous Peplin AK
study)

- Early termination from study PEP005-020

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Summarize treatment area recurrence of AK lesions in the selected treatment area

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-031

NCT ID:

NCT00952783

Start Date:

July 2009

Completion Date:

October 2010

Related Keywords:

  • Actinic Keratosis
  • Peplin
  • Actinic keratosis
  • PEP005
  • Keratosis
  • Keratosis, Actinic

Name

Location

Henry Ford Health SystemsDetroit, Michigan  48202
Oregon Health and Science UniversityPortland, Oregon  97201
Park Avenue DermatologyOrange Park, Florida  32073
Dermatology Associates of RochesterRochester, New York  14623
Gwinnett Clinical Research Centre2383 Pate St, Snellville, Georgia  30078-3250
Medaphase IncNewnan, Georgia  30263
Dermatology Research AssociatesNashville, Tennessee  37203
Michigan Center for Research CorpClinton Twp, Michigan  48038